Due to the high number of audits required, it is essential that Marketing Authorisation Holders (MAH) and their service providers are prepared and are able to present their companies in the best possible light in the short period of time available. This article considers how to best prepare for and host a licensing partner audit from the auditee’s perspective.
Preparing to be audited
When preparing to be audited, about half of your time will be occupied with the ‘known’ preparation tasks such as agreeing the scope and agenda, and responding to document requests. The other half is more an anticipation of ‘unknown’ requirements that may arise during the audit. Both aspects of audit preparation are essential to ensure that an audit runs smoothly and that there are no major surprises.
Following the announcement of an audit, there will be a period of time before the audit takes place. Some companies will announce their audit plan for the next calendar year at the beginning of Q4, while others will only give one month’s notice. To ensure that you do not encounter last-minute audit requests, it is advisable to make sure your Pharmacovigilance Agreement (PVA/SDEA) states a minimum notice period for audits. This notice period, while not linked to an individual audit, is important as it will allow your company sufficient time for audit preparation. By having a minimum notification period, you will avoid the stress of a last-minute audit and you will have sufficient time to prepare effectively.
The three essential preparation tasks to carry out before you host an audit are to ensure an appropriate scope, achievable agenda and efficient response to pre-audit document requests. These three tasks are essential for a successful audit to be conducted and are the bare minimum for completion.
Following the notification of an audit, an audit scope should soon follow. Upon receipt of the audit scope, make sure that it covers the appropriate legislation and the correct agreement with the licencing partner. If either of these things are incorrect or do not align with your understanding of the work conducted with the partner then raise your concerns with them and/or the auditor. It may be a simple mistake, or it may be something which needs further clarification and action, and quite possibly before the audit commences.
The audit agenda should cover your PV system or the PV tasks that you perform as stated in your agreement with the partner. Agendas will vary depending on who is auditing, the type of audit, and the scope of the audit. Before approving the agenda, ensure that all proposed agenda items are appropriate and in line with the relevant PVA. Again, if there are any items that are inappropriate or out of scope, the auditor and partner should be informed. If all is correct then the agenda should be updated to list all interviewees. When completing an agenda, ensure that the staff listed as interviewees are available for the audit at the scheduled times. In case of absence, ensure that a back-up interviewee has been identified and is on stand-by.
Upon finalisation of the audit agenda, it should be sent to all audit interviewees to allow them to mark-up their diaries appropriately. It is worth reminding the audit interviewees that audits do not always run to schedule and that the agenda may change depending on how earlier interview sessions go. Interviewees should be prepared to be flexible and work to the auditor’s schedule.
Pre-audit Document Requests
Around one month to two weeks prior to the audit, the auditor may ask you to provide a number of documents in advance. The documents requested will often include the PSMF, a list of PV SOPs, the relevant PVA, an organisation chart, computerised system validation documentation, training records, a history of communications with competent authorities, a list of competent authority inspections and a business continuity/disaster recovery plan. It is essential that these document requests are dealt with efficiently to ensure that they are sent to the auditor with enough time for them to review before the beginning of the audit. As these are the first documents that you will be presenting to the auditor, they should be reviewed meticulously to ensure that there are no errors and to create a good first impression. The pre-audit document requests should follow the same process and system that will occur during the audit itself. There is no difference in these pre-audit requests and the requests that will be received during the audit.
In addition to the three essential preparation tasks described above, it is worthwhile trying to establish whether there was a trigger for the audit. Knowing the reason for the audit will help you prepare interviewees to answer questions appropriately and avoid any questions coming as a surprise during interview.
Upon notification of the audit, start to review all interaction that has occurred between you and the licencing partner. Has a risk assessment been completed in the past two years? Have any deviations been raised that were communicated to the licencing partner? Have you undergone an inspection which might have been notified to the licencing partner?
It is a good idea to contact key personnel who have interacted with the licencing partner and determine if there are any other issues that have arisen in the past year. Review this information as well as any other communication which may have taken place between you and the licencing partner. If anything is discovered during this investigation, it may be beneficial to assemble the interviewees and relevant managers to discuss the audit and the possible questions that may be raised. This will allow everyone to settle any discussions outside of the audit room and before a single question is asked by the auditor.
It is also worthwhile setting up a presentation for all interviewees and relevant managers before the audit. It can be useful to present information about the licencing partner and the auditor themselves (we are checking you out on LinkedIn auditors!). It is an excellent opportunity to prepare staff with an overview of the audit, providing information such as the nature of the agreement with the licencing partner, the relevant contact persons, and the delegation of responsibilities. It also provides an environment for interviewees to ask questions in advance of the audit.
During an audit
On the day of the audit, everyone hopes that the auditor arrives in a good mood after a smooth journey to your premises, the agenda is followed strictly, interviewees are asked questions which have been prepared for, and all document requests are easy to find. However, in reality this is very often not the case. Undoubtedly something will not go according to plan on the day; a fire alarm will go off and disrupt the day’s agenda, the auditor has dietary requirements that have not been taken into account by your caterers, or an interviewee is unexpectedly out of the office and a back-up interviewee is in a panic!
There are two ways to mitigate the stress from such unforeseen circumstances. The first is to prepare – if you try to pre-empt these situations and put a back-up plan in place then you can reduce the stress and panic that often accompanies an audit day. The second is to nominate an ‘audit co-ordinator’ to be responsible for the audit on the day. The audit co-ordinator is the person who should greet the auditor, have them sign into the office building, and show them to the audit room where they will be based for the duration of the audit (and also get them a coffee or tea, preferably with sugar to sweeten them up). The audit co-ordinator should be informed of all issues that arise during the audit that may affect the audit day. It is their responsibility to deal with any issues or delegate responsibility to an appropriate person. Having one person in charge of the audit ensures co-ordination of all activities and means that there is no duplication of work and unnecessary panic. The audit co-ordinator is not necessarily in charge of the back-room, which we discuss shortly, but the two roles often do go hand in hand. Having one person in charge of the audit means that all staff know who to pose questions or direct issues to.
One of the main criteria for ensuring a successful audit is an organised back-room. The back-room is responsible for providing the auditor with all requested documents in a timely manner.
Upon the completion of an audit interview, a document request form completed by the auditor should be provided to the back-room. The back-room should already have been advised how documents will be received and reviewed by the auditor (via the audit co-ordinator). The back-room needs to review the request list and send out notifications to the relevant personnel requesting the evidence promptly. All documents should be returned to the back-room before the auditor’s final document review session which often occurs on the final day of the audit. Documents should be provided to the back-room on the day of request. Upon completion of a document request form, the audit co-ordinator will check with the auditor which documents they would like to review first and establish any particular priorities. The key thing is to get all documents to the auditor on the day requested unless otherwise agreed.
To ensure the back-room is efficient in providing documentation, it is essential to brief all back-room personnel before the audit and have a clear process in place. It is also the role of the back-room to review all audit documentation before it is provided to the auditor. They should check not only that the document is correct as per the request but also that all redaction has been completed, all formatting is correct, page numbers, titles, signatures are in place, and that all documents are ‘protected’ if being provided electronically.
While many people now prefer to work electronically, there are still some auditors who prefer to receive all documents in hard copy. The back-room should be prepared for both situations. Many companies will provide the back-room with a dedicated printer so that there is no delay or mix-up with general office use. Ask the auditor in advance how they would like to receive documentation so that you can prepare. All auditors conduct audits differently, some are document request heavy while others prefer interviews. Should a document request heavy auditor arrive, the back-room needs to be ready to work hard for the duration of the audit (and maybe longer) preparing documents in a swift manner. The key to a successful back-room is planning, clear processes and training. By training your back-room personnel on a clear process, you should enable the back-room to work effectively under a heavy workload.
While some MAHs require a scribe to be present during the whole audit, it is not always necessary or possible. However, it is certainly advisable that a scribe be present for the opening and closing meeting of the audit. The opening meeting can provide information regarding the reason for the audit, what is to be expected during the audit day, and it is an opportunity to raise any questions with the auditor before interviews begin. It is essential that the closing meeting is recorded as initial feedback will be provided by the auditor. The initial feedback should include an indication of where findings have been made and what grading to expect. In the closing meeting, make sure that timeframes are provided for when the audit report can be expected and how long you will have to prepare a CAPA response document. This will allow you to track timelines and organise workload so that you have capacity to begin work on the CAPA response document as soon as the audit report is received.
Finally, the one thing that will often catch people out during an audit is technology. As much as technology has advanced our lives, it always seems to fail at those crucial moments! Be sure to test your internet connection with an external laptop so the auditor can access the internet with no issues. Test any conference call systems that may be used to interview external staff; if using an internet-based programme, it may be worth having a telephone conference line available as an alternative in case of any issues. Clarity through microphones and speakers is often an issue so set up a test call in advance of the audit. If providing documents on a memory stick, be careful of compatibility issues and have an alternative means of document transfer available. IT issues cause the most stress due to most people’s lack of IT knowledge, therefore have back-up plans in place for anything technical so that you can avoid the IT fear!
Preparing and hosting an audit can be stressful due to the high workload, tight timeframes and often high stakes, but as we all know audits can be extremely useful and we should make the most of the time to reflect and review. As a trainee auditor at Panacea, a PV service provider, I have hosted, managed, and conducted many audits on behalf of numerous clients. In my time at Panacea, I have learnt that preparation is key and communication vital.
*Please note that this article is written in the opinion of Trainee Auditor, Emma Wilcox.
If you wish to speak to anyone at Panacea with regard to hosting or conducting audits then please contact PanaceaQA@panacea.im